> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Opna Bio Wins FDA Fast Track for Multiple Myeloma Drug
- URL: https://www.fdaweb.com/opna-bio-wins-fda-fast-track-for-multiple-myeloma-drug/
- Published: 2026-04-17T12:00:00.000Z
- Updated: 2026-09-14T13:37:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161004

FDA has granted Opna Bio a fast track designation for its investigational therapy OPN-6602 and its use in treating patients with relapsed or refractory multiple myeloma who have undergone at least four prior lines of therapy.

The oral small-molecule inhibitor targeting EP300 and CREB-binding protein is currently being evaluated in a Phase 1 clinical trial assessing safety, tolerability, pharmacokinetics and early signs of clinical activity.

Multiple myeloma, a cancer of plasma cells in the bone marrow, remains largely incurable despite recent therapeutic advances, with many patients eventually relapsing or becoming resistant to available treatments.